MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. BIOMET BC R 1X40 US; BONE CEMENT

Catalog Number	110035368
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Joint Laxity (4526)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) mdr-report key: 23598008.Mdr-report #: mw5179086.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient underwent a knee revision to a total knee replacement due to loosening and significant polyethylene wear.Following an initial partial knee replacement, symptoms developed approximately a few months later, including pain, deformity, limited range of motion, weakness, and instability.A computed tomography scan performed approximately several months after symptom onset showed lucency at the tibial and femoral bone interface.Bloodwork was performed to rule out infection.Intra-operatively during the revision, findings included significant polyethylene wear, gross loosening of the tibial implant, anterior cruciate ligament deficiency, and full-thickness cartilage loss in the remaining compartments.A computed tomography scan performed approximately one year earlier showed only a mild degree of degenerative osteoarthritis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET BC R 1X40 US
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23954708
• Report Number: 3006946279-2026-00001
• Device Sequence Number: 9447944
• Product Code: LOD
• UDI-Device Identifier: 00887868214578
• UDI-Public: (01)00887868214578(17)251231(10)AW05BB0603
• Combination Product (Y/N): N
• PMA/510(K) Number: K172408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 110035368
• Device Lot Number: AW05BB0603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG